PETS-D: Impact on Diabetes Management Outcomes.

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To evaluate the efficacy of Parent Education Through Simulation-Diabetes (PETS-D; clinical trial registration NCT01517269) for parents of children <13 years old newly diagnosed with type 1 diabetes with 3 parent education vignette sessions using human patient simulation (HPS) as compared with formal parent-nurse education sessions (vignette only) regarding diabetes knowledge, problem-solving skills, hypoglycemia fear, anxiety, and self-efficacy. Subjects were randomized to the HPS parent diabetes education or the vignette-only arm. Using linear mixed modeling, we compared HPS and vignette-only groups at 2, 6, and 14 weeks. Effect modification of treatment by dichotomized child's age (<6 and ≥ 6 years old) and parent education (≤ high school and >high school) was also tested. All analyses were intent to treat and adjusted for baseline outcome level and clustering within site. We recruited 191 parents (116 children). Mean baseline A1C was 12%. Overall treatment-related differences were modest. There was a statistically significant effect modification of HPS by child's age, with a larger HPS benefit among parents of younger children for several outcomes: A1C (8.16% vs 9.48% in control; P = .006), lower state anxiety (P = .0094), and higher fear of hypoglycemia (P = .03) for parents of children <6 years old in the HPS group. Modest treatment-related differences may reflect ceiling/floor effects in many of the outcomes; we also compared HPS with another intervention rather than to usual education. Parents of younger children receiving the intervention may feel more comfortable with lower A1C levels because of management awareness gleaned from the HPS experience. Future research will include a retrospective case-control study of very young children.